BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREE-WAY PLASTIC STOPCOCK

    MDR report key: 6178599 · Received December 15, 2016

    Report

    Report Number
    1820334-2016-01474
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    November 15, 2016
    Report Date
    June 6, 2017
    Manufacturer
    COOK INC
    Product Code
    KGZ
    UDI-DI
    00827002002197
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, MANUFACTURER INSTRUCTIONS, FUNCTIONAL TESTING AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. TWO THREE-WAY PLASTIC STOPCOCKS WERE RETURNED FOR EVALUATION. BOTH ARE COVERED IN A RED LIQUID THAT DID NOT APPEAR TO BE DRIED BLOOD. A 2 MILLIMETER (MM) CRACK WAS NOTED AT THE BASE OF BOTH STOPCOCKS. THE STOPCOCK LEVERS COULD BE MANIPULATED. THE STOPCOCKS WERE LIQUID LEAK TESTED USING A 5 MILLILITER (ML) SYRINGE, AND BOTH FAILED. LEAKING OCCURRED AT THE LOCATION OF THE CRACK. THE HEX NUT WAS NOTED TO BE PINNED SECURELY AND PROPERLY ALIGNED. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A TACE (TRANS CATHETER CHEMOEMBOLIZATION) PROCEDURE BLOOD WAS NOTED TO BE LEAKING FROM THE STOPCOCK DEVICE. THE DEVICE WAS REPLACED WITH ANOTHER AND THE PROCEDURE WAS COMPLETED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827544 THREE-WAY PLASTIC STOPCOCK KGZ ACCESSORIES, CATHETER KGZ COOK INC N/A 00827002002197

    Patients

    Seq Age Sex Outcome Treatment
    1